Kornimate/medical-research-clean huggingface dataset:
assessment of the reactogenicity of adacel® (tdcp vaccine) in children and adolescents 7 to 19 years of age

Conditions: Pertussis; Diphtheria

Summary: to compare the reactogenicity of adacel® vaccine given at intervals of 2 to 9 years with the reactogenicity of adacel® vaccine given at an interval of 10 or more years following the last previous administration of vaccine containing diphtheria and tetanus toxoids (referred to as td/td).


Eligibility criteria:
inclusion criteria: * age \> 7 years and \< 20 years. * signed and dated irb-approved informed consent form obtained from the participant, parent or legal guardian prior to the first study intervention. * judged to be in good health on the basis of reported medical history. * available for planned length of the study. * participant or parent or legal guardian (as applicable) can read and write english and can understand the informed consent documents and the study instructions. a participant eleven years of age or older who meets an exclusion criterion may not be enrolled in the study but nonetheless may participate in the vaccination program, at the discretion of the prince edward island public health authorities). a participant younger than eleven years of age who meets an exclusion criterion may not be enrolled in the study and may not participate in the vaccination program. exclusion criteria: * known or suspected allergy to adacel®, any of the vaccine's components, or prior allergic reaction to diphtheria or tetanus toxoids or acellular pertussis vaccine. * planned receipt of any other vaccine within the 14 days following administration of adacel® vaccine in this study. * any other medical condition that in the opinion of the investigator would cause an unexpected hazard or interfere with the study objective. * receipt of td/td within the preceding 12 months. * known or suspected to be pregnant. a participant eleven years of age or older who meets an exclusion criterion may not be enrolled in the study but nonetheless may participate in the vaccination program, at the discretion of the prince edward island public health authorities). a participant younger than eleven years of age who meets an exclusion criterion may not be enrolled in the study and may not participate in the vaccination program.

Keywords: pertussis tetanus diphtheria
a study to evaluate the efficacy and safety of 2.5mg and 5mg tadalafil given once a day to men with erectile dysfunction

Conditions: Erectile Dysfunction

Summary: this is a multicenter, randomized, double blind, placebo-controlled, parallel design study to evaluate the efficacy and safety of 2.5mg and 5mg tadalafil taken once daily in men with erectile dysfunction.


Eligibility criteria:
inclusion criteria: * men with erectile dysfunction * at least 18 years of age exclusion criteria: * certain chronic medical conditions including cardiac disease, congestive heart failure, kidney or liver disease, cancer and hiv * a history of certain impotence disorders * history of specified pelvic surgery * any significant genital abnormality identified at the start of the study

Keywords: impotence erectile dysfunction
cognitive remote assessment using flame (cra-flame)

Conditions: Cognitive Impairment

Summary: we aim to use a multimodal approach comprising conventional neuropsychological cognitive tests, fluid and imaging biomarker data, to explore their association with the flame unsupervised cognitive computerized assessment. we believe that this would provide critical information to move forward the current research framework in the field. participants will be selected from bbrc-sponsored studies, such as the alfa project (study 45-65 fpm/2012), the alfa+ cohort study (alfa - fpm - 0311), the beta-aarc study (β-aarc_bbrc2020) or the barcelonabeta dementia prevention research clinic study (bbrc-demprev-2018)

we aim to use a multimodal approach comprising conventional neuropsychological cognitive tests, fluid and imaging biomarker data, to explore their association with the flame unsupervised cognitive computerized assessment. we believe that this would provide critical information to move forward the current research framework in the field. participants will be selected from bbrc-sponsored studies, such as the alfa project (study 45-65 fpm/2012), the alfa+ cohort study (alfa - fpm - 0311), the beta-aarc study (β-aarc_bbrc2020) or the barcelonabeta dementia prevention research clinic study (bbrc-demprev-2018)

Eligibility criteria:
inclusion criteria: participants must meet all the following criteria: 1. to sign the study informed consent form approved by the corresponding authorities. 2. men and women that have participated/are participating in a bbrc-sponsored study. 3. to accept that: * the results obtained in this study may be published in scientific journals and at bbrc's communication channels (e.g. web page) * the data gathered may be used in combination with those gathered in other bbrc-sponsored studies in which they may (have) participate(d) exclusion criteria: 1. not having an ict literacy enough to access and complete the online tests.
the general use of robots in stroke recovery: the anklebot

Conditions: Stroke

Summary: the purpose of this study is to determine if isolated robot-assisted training of the ankle joint improves chronic hemiparetic gait in patients after stroke.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * first single focal unilateral lesion with diagnosis verified by brain imaging, which occurred at least 6 months prior * cognitive function sufficient enough to understand experiments and follow instructions * some amount of independent ambulation (with orthoses or walker) exclusion criteria: * botox treatment within 6-weeks of enrollment; * fixed contraction deformity in the affected limb; * complete and total flaccid paralysis of all lower extremity motor function; * unable to ambulate except with the aid of another person

Keywords: stroke cva cerebrovascular accident cerebral stroke robotic therapy anklebot physical therapy
satraplatin for locally advanced non-small cell lung cancer with simultaneous radiotherapy

Conditions: Carcinoma, Non-small Cell Lung; Lung Cancer

Summary: purpose: this trial is designed to compare the combination of the investigational oral cytotoxic drug, satraplatin, and radiation therapy for patients with locally advanced non-small cell lung cancer (nsclc) with no prior chemotherapy or radiation therapy treatment. please refer to the eligibility criteria below for key inclusion and exclusion criteria. what is satraplatin: satraplatin is an oral, investigational anticancer drug that is a member of the platinum-based class of chemotherapy drugs. platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. unlike the currently marketed platinum-based drugs, satraplatin can be given orally. rationale: intravenously administered platinum-based drugs are currently used in combination with radiation therapy in the treatment of patients with locally advanced nsclc. the purpose of this phase i trial is to determine a tolerable dose and schedule for the oral platinum drug (satraplatin) when given to nsclc patients throughout the course of their radiotherapy treatment.


Eligibility criteria:
inclusion criteria: * locally advanced or medically inoperable nsclc (stage ii or iii) * ecog performance status score 0-2 * adequate bone marrow, liver, and pulmonary functions * life expectancy \> three months. exclusion criteria: * prior malignancy * serious concurrent uncontrolled medical disorder. * uncontrolled or significant cardiovascular disease * history of mastectomy * pregnant or breast-feeding patients are not eligible * prior radiotherapy to the primary tumor site or cytotoxic chemotherapy

Keywords: non-small cell lung cancer (stage ii or iii) nsclc squamous cell lung cancer adenocarcinoma of the lung adenosquamous cell lung cancer bronchoalveolar cell lung cancer carcinoma, non-small cell lung
effect of oral gs-6615 on dofetilide-induced qt prolongation, safety, and tolerability in healthy adults

Conditions: Long QT Syndrome

Summary: this study will evaluate the effect of oral gs-6615 on qtc interval in healthy adults with dofetilide-induced qtc prolongation.


Eligibility criteria:
inclusion criteria: * must, in the opinion of the investigator, be in good health based upon medical history and physical examination, including vital signs * have a calculated body mass index (bmi) from 18 to 30 kg/m\^2, inclusive, at study screening * have either a normal 12-lead electrocardiogram (ecg) or one with abnormalities that are considered clinically insignificant and which do not interfere with the ability to interpret the qt interval in the opinion of the investigator in consultation with the medical monitor exclusion criteria: * history of meningitis or encephalitis, epilepsy, seizures (known or suspected), migraines, tremors, myoclonic jerks, sleep disorder, anxiety, syncope, head injuries, or a family history of seizures * have any serious or active medical or psychiatric illness (including depression) which, in the opinion of the investigator, would interfere with treatment, assessment, or compliance with the protocol. this would include renal, cardiac, hematological, hepatic, pulmonary (including chronic asthma), endocrine (including diabetes), central nervous, gastrointestinal (including an ulcer), vascular, metabolic (thyroid disorders, adrenal disease), immunodeficiency disorders, active infection, or malignancy that are clinically significant or requiring treatment. * presence or history of cardiovascular disease, including structural heart disease, myocardial infarction (by ecg and/or clinical history), history of ventricular tachycardia or torsade de pointes, heart failure or cardiomyopathy (by clinical history and/or left ventricular ejection fraction \< 40%), presence of cardiac conduction abnormalities, a family history of long qt or brugada syndrome, or unexplained death in an otherwise healthy individual between the ages of 1 and 30 years * additional cardiovascular-specific exclusion criteria include findings on screening ecg of: * qtcf interval \> 430 msec * pr interval \> 220 msec * qrs duration \> 110 msec * second- or third-degree atrioventricular block * complete left or right bundle branch block or incomplete right bundle branch block * resting heart rate \ 100 beats per minute (bpm) * pathological q waves (defined as q wave \> 40 msec) * ventricular pre-excitation * more than 2 ectopic beats * syncope, palpitations, or unexplained dizziness

Keywords: drug-induced long qt syndrome dilqts prolonged qt
a phase i study of cci-779 (temsirolimus) in combination with topotecan in patients with gynecologic malignancies

Conditions: Genital Neoplasms, Female

Summary: the aim of the trial is to determine the recommended phase ii dose of weekly intravenous topotecan in combination with a fixed dose (25 mg or 15 mg) of weekly intravenous temsirolimus in patients with and without prior pelvic radiation.


Eligibility criteria:
inclusion criteria: * histologically confirmed recurrent or metastatic ovarian carcinoma, fallopian tube carcinoma, primary peritoneal carcinoma, cervical carcinoma, endometrial carcinoma, vulvar carcinoma, vaginal carcinoma, or carcinosarcoma of the ovary, endometrium or cervix. * prior therapy: at least one and may have up to three prior cytotoxic chemotherapeutic regimens for the management of primary disease. * must be at least 18 years of age. * gog performance status must be 0 or 1. * patients must have adequate organ and marrow function as defined below: * hemoglobin ≥10g/dl * absolute neutrophil count ≥1,500/ul * platelets ≥100,000/ul * total bilirubin below the institutional upper limit of normal * ast(sgot)/alt(sgpt) below the institutional upper limit of normal * creatinine below the institutional upper limit of normal * cholesterol ≤ 350 mg/dl (fasting) * triglycerides ≤ 400 mg/dl (fasting) * albumin ≥ 3.0 mg/dl * negative pregnancy test for women able to have children * ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * prior therapy with topotecan * more than 3 prior cytotoxic chemotherapeutic regimens or treatment with temsirolimus or any other mtor inhibitor * concomitant hormonal therapy or radiation therapy * clinically significant infections or other medical problems of significant severity * history of unstable angina or myocardial infarction within the past six months * known brain metastases unless the metastases have been controlled by prior surgery or radiotherapy, and the patient has been neurologically stable and off of steroids for at least 4 weeks. * any requirement for oxygen * cannot be receiving potent enzyme-inducing antiepileptic drugs (eiaeds; e.g., phenytoin, carbamazepine, phenobarbital) nor any other potent cyp3a4 inducer such as rifampin or st. john's wort, as these may decrease temsirolimus levels. use of agents that potently inhibit cyp3a4 (and hence may raise temsirolimus levels), such as ketoconazole, is discouraged, but not specifically prohibited.

Keywords: ovarian cancer cervical cancer uterine cancer fallopian tube cancer endometrial cancer vaginal cancer peritoneal cancer reproductive cancer
vascular and metabolic effects of omega-3 fatty acids

Conditions: Hypertriglyceridemia

Summary: the investigators hypothesize that omega does-dependently improves vascular and insulin resistance.


Eligibility criteria:
inclusion criteria: * hypertriglyceridemia exclusion criteria: * overt liver disease, chronic renal failure, hypothyroidism, myopathy, uncontrolled diabetes (hba1c \> 9%), severe hypertension, stroke, acute coronary events, coronary revascularization within the preceding 3 months, or alcohol abuse

Keywords: insulin resistance
4 dimensional - impairment of posttraumatic forearm rotation evaluated with computed tomography

Conditions: Pronation-Supination of the Forearm, Impairment of

Summary: the aim of this study is to develop a 4d-ct (4 dimensional computed tomography) -scan acquisition method for estimating the cause of posttraumatic impairment of the forearm. both forearms of patients with posttraumatic impairment of one of the forearm will be scanned using a 4d-ct-scan, during forearm rotation. rotation of impaired and healthy forearms will be analysed and compared to each other. this method is intended to allow differentiation of motion patterns reflecting an osseous impairment from those caused by soft tissue pathology in order to improve treatment choice.

forearm and wrist fractures are the most common of all fractures and mostly occur at the distal end of the radius. distal radius fractures are associated with posttraumatic sequelae, which typically involve restricted forearm rotation. diagnostics of dynamic traumatic pathologies are conventionally based on static (2d or 3d) imaging protocols using mri (magnetic resonance imaging) or ct. however, interpretation of indirect suggestive findings - such as edema or abnormal bone positions - limits accuracy and inter-observer reliability. dynamic 4d imaging (adding the fourth dimension of time) has the potential to discriminate whether forearm rotation deficit is due to an osseous deformity causing bony impingement or whether it is due to non-osseous pathology. hence it may reduce unnecessary corrective osteotomies and guide the patient and surgeon towards the most effective surgical or conservative treatment choice - expectedly resulting in better outcomes and patient satisfaction. in addition, we aim to develop a classification based on the estimated motion patterns and assess its reliability. furthermore we aim at acquiring knowledge of physiological mechanics of the radioulnar joint and to assess symmetry in radioulnar joint motions between two healthy forearms on 4d-ct-scans.

Eligibility criteria:
inclusion criteria: * patients with a one-sided posttraumatic impairment of forearm pro- and/or supination at least 3 months after injury * patients are above 18 years * patients who are willing to give informed consent * national health insurance cover exclusion criteria: * a history of trauma to both forearms * any shoulder pathology or impairment preventing forward elevation of the arm as required during the scanning protocol * neuromuscular pathology * not able to understand or give informed consent * pregnancy (βhcg positive), breast-feeding or the absence of effective contraception for women of child-bearing age * legal incapacity (persons in custody or under guardianship) * deprived of liberty subject (by judicial or administrative decision)

Keywords: four dimensional computed tomography (4d-ct)
a study of aripiprazole in patients with bipolar i disorder with a major depressive episode

Conditions: Bipolar I Disorder

Summary: the purpose of this study is to evaluate several doses of aripiprazole in patients with bipolar depression.


Eligibility criteria:
inclusion criteria: * men and women, ages 18-65 * have experienced a prior manic episode that required treatment with a mood stabilizer or antipsychotic, and now meet criteria for a major depressive episode.

Keywords: depressed
s. aureus translocation from skin and nose to periprosthetic tissues

Conditions: Staphylococcus Aureus

Summary: surgical site infections (ssi) are a significant clinical issue that requires the use of a great amount of resources. in particular, periprosthetic joint infections (pjis) have potentially catastrophic effects on patients' health-related quality of life, function, healthcare costs, outcomes and medical implications. national surveillance estimates may under-report the true incidence and when considering the large number of total hip (tha) and total knee arthroplasty (tka) procedures performed each year. patients who have a high-level of nasal bacteria have been found to have a risk of surgical site infection that is three to six times the risk compared with noncarriers and low-level carriers. the association between a patient's nasal carriage of s. aureus, specifically mrsa, and pji has been demonstrated in a systematic review and confirmed in recent cohort studies. while this association seems to be well accepted, no mechanistic explanation has been provided for this association.


Eligibility criteria:
inclusion criteria: * all patients undergoing revision total knee or total hip arthroplasty at our institution will be eligible exclusion criteria: * patients included in other prospective studies
myotonia and muscle stiffness in nmd

Conditions: Neuromuscular Disorders

Summary: the primary objective of this study is to assess stiffness, muscle tone, relaxation periods and elasticity of various muscles in patients with dystrophic or non-dystrophic myotonia. the secondary objectives are (1) to provide reference values for stiffness, muscle tone, relaxation periods and elasticity of various muscles in patients with dystrophic or non-dystrophic myotonia; to provide reference values for stiffness, muscle tone, relaxation periods and elasticity of various muscles in patients with non-myotonic neuromuscular disorders, (3) assess correlations between to compare result values for stiffness, muscle tone, relaxation periods and elasticity with clinical muscle function tests, measured by clinical evaluation (mrc-scale) and the 6-minute walk test; (4) assess correlations between subcutaneous fat and muscle thickness and echogenicity, measured by muscle ultrasound and result values for stiffness, muscle tone, relaxation periods and elasticity.


Eligibility criteria:
inclusion criteria: for patients: * ≥18 years of age * confirmed neuromuscular disease * written consent * able and willing to perform study prodcedures for healthy volunteers: * age ≥18 years of age * written informed consent * no clinical sign for neuromuscular disorders exclusion criteria: * severe comorbidities * patient is participating in another clinical study using investigational treatment * patient cannot perform required muscle function tests * the patient, in the opinion of the investigator, is unable to adhere to the requirements of the study
economic aspects associated with the implementation of an orthogeriatric setting in a general hospital

Conditions: Hip Fracture

Summary: the economic and social burden of hip fractures is expected to increase dramatically, but financial resources remain limited. this calls for the investigation of innovative new forms of organization and integration of medical, surgical and rehabilitation services for these patients. the study will investigate economical aspects associated with implementation of a comprehensive orthogeriatric ward for elderly hip fracture patients in a general hospital, compared with the classic model of orthopedic treatment followed by rehabilitation period.


Eligibility criteria:
inclusion criteria: * hip fracture exclusion criteria: * patients admitted for elective hip surgery * patients with multi-trauma injuries

Keywords: hip fracture elderly orthogeriatric cost effectiveness of hip fracture patients
how "shared decision making decision-aid" help patients with obstructive sleep apnea to choose treatment plan

Conditions: Shared Decision Making; OSA - Obstructive Sleep Apnea

Summary: shared decision-making helps patients to establish a treatment plan with clinicians together. our goal was to determine if the tools we developed could reduced decisional conflict for patients with obstructive sleep apnea.

shared decision-making helps patients to establish a treatment plan with clinicians together. our goal was to determine if the tools we developed could reduced decisional conflict for patients with obstructive sleep apnea. inclusion criteria: include obstructive sleep apnea patient from the outpatient clinic of dean wu, the sleep center of shuang-he hospital, 20-80 years old, polysomnography showed moderate severity (ahi ≥ 15), can communicate in chinese. exclusion criteria: dementia, mental illness, language difficulties.

Eligibility criteria:
inclusion criteria: * include obstructive sleep apnea patient from the outpatient clinic of dean wu, the sleep center of shuang-he hospital, 20-80 years old, polysomnography showed moderate severity (ahi ≥ 15), can communicate in chinese exclusion criteria: * exclude dementia, mental illness, language difficulties
a clinical trial to evaluate the effectiveness and safety of chinese medicine in the treatment of mild type of hand, foot, and mouth disease

Conditions: Hand, Foot and Mouth Disease

Summary: the study is aimed to evaluate the effectiveness and safety of traditional chinese medicine (tcm) for treatment of hand, foot, and mouth disease (hfmd).

by adopting a multi-center, randomized and controlled clinical trial, this study is aimed to evaluate the effectiveness, safety and economic evaluation of traditional chinese medicine for treatment of hfmd, and to provide scientific evidence for the construction of tcm methods in treating hfmd.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of severe hand-foot-mouth disease patients according to hand-foot-mouth disease treatment guidelines 2010 issued by china's ministry of health; more than 1/3 patients should be diagnosed by etiological examination. * less than 48 hours of occurrence of fever and/or occurrence of tetter or herpes. * age of 1-14 years. * patients or their guardians agree to participate in this study and signed the informed consent form. exclusion criteria: * complicated with other serious primary diseases in organ such as congenital heart disease, chronic hepatitis, nephritis and blood diseases, etc. * with history of allergies on traditional chinese medicine. * patients or their guardians suffering from psychiatric diseases. * attending other clinical studies on hfmd after diagnosed.

Keywords: mild type of hand, foot and mouth disease traditional chinese medicine effectiveness safety